Underlying all successful therapeutic approaches is the initial diagnosis of the particular disease. A challenge to medicine since its inception has been to conceive of methods that permit rapid and accurate detection of diseases. Despite advances in diagnostic technology over the years, the current techniques for the diagnosis of many diseases are often inadequate or cost prohibitive for wide scale application.
Many diagnostic techniques involve detection of specific substances which may be present, or at least elevated in concentration, in only the disease state. Typically, detection of a substance itself, a molecule which recognizes the substance, or a reaction between the substance and the molecule, necessitates amplification in order to produce detectable levels. One approach to amplification is to use polymer particles having a molecule which recognizes a substance bound thereto. Such particles, when in the presence of the substance, will clump together (also known as agglutination) from an otherwise homogeneous solution. Agglutination may be detectable by visualizing the clumped particles directly or indirectly via dyed particles.
Subsequent to the introduction of the first diagnostic latex agglutination test, a number of different latex agglutination tests have been developed. However, most of the latex slide tests can be difficult to interpret and the length of the required "hands on time" can lead to false positives (i.e., a result is obtained which indicates that a substance is present in a sample when in fact it is not). Other tests may be easier to interpret, but are costly to manufacture. Thus, there is a need in the art for detection assays and kits which are rapid, accurate, cost-effective, and convenient. The present invention fulfills these needs and further provides other related advantages.